Label comprehension study for a proposed over-the-counter progestin-only pill

Area of Science:

• Reproductive Health
• Pharmacology
• Consumer Health Education

Background:

• The progestin-only pill (POP) norgestrel 0.075 mg was considered for over-the-counter (OTC) availability.
• Assessing user comprehension of the proposed Drug Facts Label (DFL) is crucial for OTC drug safety and efficacy.

Purpose of the Study:

• To evaluate the understanding of key messages within the proposed DFL for norgestrel 0.075 mg POP.
• To determine if potential users could adequately comprehend information for self-selection and appropriate use.

Main Methods:

• Videoconference interviews were conducted with 703 individuals aged 11-50, encompassing diverse populations in the US.
• Comprehension of 14 primary and 19 secondary DFL messages was assessed against predefined thresholds.
• Statistical analysis included evaluating the lower limit of the 95% confidence interval (CI) for primary endpoints.

Main Results:

• Nine out of 14 primary DFL messages met or exceeded the 90% comprehension threshold.
• All five remaining primary messages showed high understanding, with point estimates >=85% and lower CI limits >82%.
• Sixteen of 19 secondary DFL messages demonstrated comprehension by 90% or more of participants.

Conclusions:

• The DFL for norgestrel 0.075 mg POP was found to be well-understood by a diverse group of potential users.
• The label information appears sufficient for individuals to self-select and use the contraceptive effectively.
• These findings contributed to the US Food and Drug Administration's approval of norgestrel 0.075 mg for nonprescription status.